The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

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Call for papers – Deadline for inquiry submissions is April 1!

February 13, 2024 by Janice Reichert

The Antibody Society’s latest analysis of the current early-stage clinical pipeline of antibody therapeutics shows that the biopharmaceutical industry is engaging in innovative research and development. For both cancer and non-cancer indications, ~60% of the antibody therapeutics in early-stage clinical development target novel antigens, and a growing portion of those against well-validated targets have been designed in novel formats (e.g., bispecifics, bispecific biparatopics, antibody-drug conjugates (ADCs), Fc engineered, hybrid isotype, immunoconjugates).

For mAbs’ next Collection, we invite The Antibody Society members, mAbs readers, and the broader scientific community to contribute review articles focused on innovative approaches for antibody therapeutic discovery. The reviews should narrate the state of the art on innovative formats, targets, or platforms for antibody therapeutic discovery, and speculate on new vistas for the field.

mAbs will waive publication charges for up to 8 of the best review articles selected from pre-submission inquiries, which should include the proposed authors, title, abstract, and general outline of the intended review article.

The deadline for pre-submission inquiries is April 1, 2024.
Authors will be notified of the Editors’ decision by April 15, 2024.
The deadline for submission of the completed review articles is December 15, 2024.

We are particularly interested in reviews on the following topics:

  • Novel platforms for antibody therapeutic discovery (e.g., novel target/epitope selection, novel approaches for enhancing or reducing Fc effector function, novel methods for enhancing antibody therapeutics half-life).
  • Novel targets or formats for cancer immunotherapy (i.e., novel antigens and formats for targeting tumors, immune cells, and the tumor microenvironment), design strategies for novel approaches in cancer immunotherapy.
  • Novel targets or formats beyond oncology (e.g., autoimmune diseases, cardiovascular/hemostasis, neurology, infectious disease, ophthalmology, rare diseases).
  • Novel immune-modulating antibodies (i.e., novel immune checkpoints and immune agonists), relevant design strategies, formats, applications and considerations for safety and tolerability in multiple disease areas.
  • Innovative format combinations (e.g., Bispecific/Multispecific ADCs, Bispecific/Multispecific checkpoint inhibitors), design strategies for these molecules and considerations for safety.
  • Novel formats for well-validated targets, relevant design strategies and considerations for efficacy, biodistribution and safety.

Although these topics are especially of interest, we welcome well-written reviews in related areas as well.

Please send pre-submission inquiries that include the authors, title, abstract, and general outline of the intended review article to Editor-in-Chief Dr. Janice Reichert (reichert.biotechconsulting@gmail.com) and Guest Editors Drs. Silvia Crescioli (silvia.crescioli@antibodysociety.org) and Kristina Ilieva-Babinsky (k.m.ilieva@gmail.com), and Prof. Jamie Spangler (jamie.spangler@jhu.edu). Please feel free to contact us if you have any questions.

Examples of other mAbs Collections can be found here.

Filed Under: Antibody discovery Tagged With: antibody discovery, antibody therapeutics, innovation

Crovalimab approved in China

February 8, 2024 by Janice Reichert

On February 8, 2024, Chugai Pharmaceutical Co., Ltd. announced that crovalimab (Chinese product name : 派圣凯®) was approved in the People’s Republic of China for treatment of adults and adolescents with paroxysmal nocturnal hemoglobinuria (PNH) not been previously treated with complement inhibitors. The regulatory application was filed by a China affiliate of F. Hoffmann-La Roche Ltd. because Roche is responsible for the development of crovalimab outside Japan and Taiwan. China is the first country in the world to approve crovalimab. Marketing applications for crovalimab have been submitted to regulatory agencies in the US, EU, and Japan.

Crovalimab (SKY59, RG6107, RO7112689) is a complement C5 inhibiting, humanized IgG1k antibody without effector functions that was engineered (M428L/N434A) to have enhanced affinity to FcRn at an acidic pH to extend its plasma half-life. Based on Chugai’s Recycling Antibody® technology, crovalimab is engineered to bind its antigen repeatedly, enabling sustained complement inhibition at a low dose administered subcutaneously (SC) every 4 weeks. Moreover, crovalimab binds a different epitope of C5 compared to existing antibody drugs, suggesting that it represents an alternative option for patients with PNH with a specific C5 gene mutation.

Crovalimab was granted Breakthrough Therapy for PNH by NMPA and the marketing application for crovalimab, which included data from the China-specific Phase 3 COMMODORE 3 study (NCT04654468), was accepted by NMPA under Priority Review.

COMMODORE 3 was a multicenter single-arm trial studying crovalimab in C5 inhibitor-naive patients with PNH in China. Patients (n=51) received crovalimab according to a weight-based dosing schedule, including loading (intravenous (IV) dose on Days 1 and 4, weekly SC doses starting from Day 2) and SC maintenance doses (every 4 weeks starting from Week 5); treatment continued after 24 weeks in patients with clinical benefit. The co-primary efficacy endpoints of hemolysis control and transfusion avoidance (TA) were met. The mean proportion of participants with hemolysis control from Week 5 through to Week 25 was 78.7% (95% CI: 67.8%, 86.6%).1 The difference between the proportion of participants with TA within 24 weeks prior to screening (0.0%) and the proportion of participants with TA from baseline through to Week 25 (51.0%) was statistically significant (p<0.0001). [1]

The global Phase 3 COMMODORE 1 (NCT04432584) and 2 (NCT04434092) studies assessed the efficacy and safety of crovalimab versus eculizumab in participants with PNH that are C5 inhibitor-experienced patients or not previously treated with complement inhibitors, respectively. COMMODORE 1 assessed safety, pharmacokinetics, pharmacodynamics, and exploratory efficacy of crovalimab. Data from the study support the favorable benefit–risk profile of crovalimab, including allowing for SC administration with the option to self-administer. [2] Data from the COMMODORE 2 study presented at European Hematology Association meeting in June 2023 in Frankfurt, Germany demonstrated that SC crovalimab Q4W was non-inferior in disease control to IV eculizumab Q2W with comparable safety for patients who have not been treated with C5 inhibitors. [3]

  1. Liu H, Xia L, Weng J, Zhang F, He C, Gao S, Jia J, Chang AC, Lundberg P, Camelia S. Sima CS, et al. Results from the first Phase 3 crovalimab (c5-inhibitor) study (commodore 3): efficacy and safety in complement inhibitor-naive patients with paroxysmal nocturnal hemoglobinuria (PNH). Presentation at: ASH Annual Meeting and Exposition; New Orleans, 2022 Dec 10-13; Abstract #293. doi.org/10.1182/blood-2022-162452.
  2. Scheinberg P, Cle D, Edwards J, Giai V, Hus M, Kim JS, Barrenetxea Lekue C, Nagy Z, Nur E, Panse J, et al. Phase III randomized, multicenter, open-label COMMODORE 1 trial: comparison of crovalimab vs eculizumab in complement inhibitor-experienced patients with paroxysmal nocturnal hemoglobinuria (PNH). Hemasphere. 2023; 7(Suppl ): e45540d8. 2023 Aug 8. doi: 10.1097/01.HS9.0000967644.45540.d8
  3. Röth A, He G, Brodsky A, Chai-Adisaksopha CC, Dumagay T, Demichelis R, Höglund M, Kelly R, Lee J-H, Nishimura J-I, et al. The PHASE III, randomized COMMODORE 2 trial: results from a multicenter study of crovalimab vs eculizumab in paroxysmal nocturnal hemoglobinuria (PNH) patients naive to complement inhibitors. Hemasphere. 2023; 7(Suppl ): e72750f1.

Filed Under: Antibody therapeutic Tagged With: antibody therapeutics, approved antibodies

World Cancer Day 2024 – Antibody therapeutics for cancer indications

February 5, 2024 by Silvia Crescioli

For World Cancer Day 2024, The Antibody Society has prepared a snapshot of the clinical development of therapeutic antibodies for cancer indication.

The infographic gives an overview on the trends in first in human studies and approvals, as well as on the active early and late stage pipelines (as of January 2024).

Filed Under: Antibody therapeutics pipeline Tagged With: ADC, antibodies, antibody discovery, Antibody drug conjugates, antibody engineering, antibody therapeutics, bispecific, cancer

The Antibody Society is hiring!

January 23, 2024 by Janice Reichert

Come join The Antibody Society in our mission to help people involved or interested in antibody research and development. We seek a Marketing and Events Manager to provide expertise in promoting our brand by managing all marketing activities, including managing and promoting events and creating marketing campaigns. This is an opportunity to be a leader in an organization that aids researchers in their development of antibody therapeutics, which improve the quality of life for many. As the Marketing and Events Managers you will take charge of:

  • Marketing for 2 major events annually, coordinating exhibit hall booth and in-person networking events
  • TAbS brand management on social media and website
  • Managing virtual events, including Symposia and webinars
  • Creating targeted marketing campaigns to attract new members and sponsors
  • Coordinating promotional activities with our partners

We seek a highly engaged individual! You are an ideal candidate if:

  •  You are passionate about the purpose and mission of The Antibody Society
  •  You are pro-active, propose new ideas, and have fun at work
  • You enjoy learning new tasks, adapting to new situations, and engaging in collaborations
  •  You value the opinions and viewpoints of others and you express your own opinions

This is a full-time, fully remote position with typical working hours 9-5 PM ET zone with the ability to flex as needed to complete required tasks. The salary range for this role is $75,000 – $85,000 annually. We offer 15 days of paid time off, a total of 12 paid holidays, and a flexible and generous health reimbursement plan.

We ask that applicants have a degree in a related field and at least 3 years of related experience, including managing online webinars, virtual symposia, and marketing at in-person trade shows.

Qualified applicants interested in the position may submit a resume with references to info@antibodysociety.org.

Filed Under: The Antibody Society Tagged With: marketing manager

Register today for the first session of the year of the AIRR-C Seminar Series

January 16, 2024 by Edel Aron

January 2024 Seminar Banner

The first AIRR-C Seminar Series session of 2024 is around the corner! On January 25th (4:00 PM – 5:30 PM CET), following the usual format of the series, an established and an early career scientist will discuss their AIRR-seq related research. Enkelejda Miho, of the University of Applied Sciences and Arts Northwestern Switzerland, will present “Integration of Clinical, Laboratory, and Multi-omics Data to Leverage Machine Learning for Diagnostics”. Next, Stefan Schattgen, of the St. Jude Children’s Research Hospital, will present “Spatiotemporal development of the human T follicular helper cell response to Influenza vaccination”.

Register now! Visit the AIRR Community Seminar Series website to learn more about this monthly series and access the recordings of past sessions.

Filed Under: AIRR Community Tagged With: Adaptive Immune Receptor Repertoire Community, Seminar

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